Cleared Traditional

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 (K191364) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence.

K191364 · Fujimori Kogyo, Co., Ltd. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
268d
Days
Class 2
Risk

K191364 is an FDA 510(k) clearance for the T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-T.... Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Fujimori Kogyo, Co., Ltd. (Shinjuku, Tokyo, JP). The FDA issued a Cleared decision on February 14, 2020 after a review of 268 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujimori Kogyo, Co., Ltd. devices

Submission Details

510(k) Number K191364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date February 14, 2020
Days to Decision 268 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 113d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03621020 Completed Observational

Clinical Performance Evaluation of T-TAS 01 PL Chip

307
Patients (actual)
6
Sites
Condition studied Platelet Dysfunction; Von Willebrand Diseases; Healthy; Congenital Platelets Abnormality
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Principal investigator Jeffrey Dahlen, Ph.D.
Sponsor Hikari Dx, Inc.
Started 2018-09-01 → Primary completion 2020-02-14
Primary outcome
Sensitivity and specificity for detecting defects in primary hemostasis
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 37
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K191364.
AggreGuide A-100 ADP
K181777 · Aggredyne, Inc. · Mar 2019
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885 · Dade Behring, Inc. · Jun 2001